FDA recall D-1147-2015

Bracco Diagnostic Inc · Class III · drug

Product

E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01

Reason for recall

Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-05-27
Report date
2015-07-01
Termination date
2016-02-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Monroe Township, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1147-2015